Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
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ClinicalTrials.gov Identifier: NCT02161783 |
Recruitment Status :
Recruiting
First Posted : June 12, 2014
Last Update Posted : December 14, 2022
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This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.
The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.
Condition or disease | Intervention/treatment |
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Primary Graft Failure Secondary Graft Failure | Drug: Fludarabine Drug: Cyclophosphamide Radiation: Total Body Irradiation Biological: Hematopoietic stem cell infusion |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation |
Actual Study Start Date : | October 6, 2014 |
Estimated Primary Completion Date : | January 24, 2032 |
Estimated Study Completion Date : | January 30, 2032 |

Group/Cohort | Intervention/treatment |
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Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
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Drug: Fludarabine
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
Other Name: Fludara Drug: Cyclophosphamide Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant. Radiation: Total Body Irradiation TBI 200cGy in a single fraction on day -1 from transplant.
Other Name: TBI Biological: Hematopoietic stem cell infusion Hematopoietic stem cell infusion given on day 0.
Other Name: HSCT |
- Rate of donor engraftment [ Time Frame: day 42 ]Rate of sustained donor engraftment at day 42 post this transplant.
- Rate of treatment related mortality [ Time Frame: day 100 ]Rate of treatment related mortality (TRM) at day 100
- Rate of survival [ Time Frame: Day 100 ]Rate of survival by day 100.
- Rate of survival [ Time Frame: 1 year ]Rate of survival at 1 year
- Incidence of acute graft-versus-host disease [ Time Frame: Day 100 ]Incidence of acute graft-versus-host disease by day 100
- Incidence of chronic graft-versus-host disease [ Time Frame: 1 year ]Incidence of chronic graft-versus-host disease at 1 year.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
- Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant.
- Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery.
- Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
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Recipients should have acceptable organ function defined as:
- Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
- Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
- Cardiac: left ventricular ejection fraction > 40%
Exclusion Criteria:
- Uncontrolled infection at the time of transplant.
- Patients with Fanconi Anemia or other DNA breakage syndromes.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161783
Contact: Timothy Krepski | 612-273-2800 | tkrepsk1@fairview.org |
United States, Minnesota | |
University of Minnesota Medical Center, Fairview | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Timothy Krepski 612-273-2800 tkrepsk1@fairview.org | |
Principal Investigator: Troy C Lund, MD, PhD |
Principal Investigator: | Troy C Lund, MD, PhD | University of Minnesota |
Responsible Party: | Masonic Cancer Center, University of Minnesota |
ClinicalTrials.gov Identifier: | NCT02161783 |
Other Study ID Numbers: |
2013OC003 MT2013-06C ( Other Identifier: University of Minnesota Blood and Marrow Transplant Program ) |
First Posted: | June 12, 2014 Key Record Dates |
Last Update Posted: | December 14, 2022 |
Last Verified: | December 2022 |
Hematopoietic stem cell transplant |
Cyclophosphamide Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |